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Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODES
IM100 Standard harness without headrest in mesh fabric
IM101 Standard harness without headrest in canvas fabric
IM110 Standard harness with headrest in mesh fabric
IM111
Standard harness with headrest in canvas fabric
IM120 Containment harness with slats in canvas fabric
IM140 Harness for bathroom and services in mesh fabric
IM141 Harness for bathroom and services with headrest in mesh fabric
IM150 Amputee harness in canvas fabric
2. INTRODUCTION
Thank you for choosing a harness in the MOPEDIA range by Moretti. Moretti harnesses have
been designed and manufactured to satisfy all your needs, for practical, correct and safe use.
This manual contains useful suggestions for using your device properly and safely. Please read
this entire manual carefully before you use the harness. Should you have any queries, please
contact your dealer for suitable advice and assistance.
3. INTENDED USE
The MOPEDIA harnesses by Moretti S.p.A. are intended for the movement of patients with
mobility impairments.
WARNING
• Do not use the product for any ' purpose other than that specified
in this manual.
• Moretti S.p.A. declines any and all liability for damages resulting
from improper use of the device or any use other than that specified
in this manual.
• The manufacturer reserves the right to modify the device and its
relevant manual without prior notice, in order to improve the
product's features.
4. EU DECLARATION OF CONFORMITY
MORETTI SpA declares, under its own exclusive responsibility, that the products made and
sold by MORETTI SpA in the PATIENT HOIST HARNESSES product family conform with the
applicable provisions of Regulation (EU) 2017/745 of 5 April 2017 on MEDICAL DEVICES.
To this end, MORETTI SpA guarantees and declares as follows, under its own exclusive
responsibility:
1. The devices in question satisfy the general safety and performance requirements set out
in Annex I to Regulation (EU) 2017/745, as prescribed by Annex IV to said regulation.
2. The devices in question ARE NOT MEASUREMENT TOOLS.
3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATION.
4. The devices in question are sold in NON STERILE packing.
5. The devices in question should be considered as belonging to class I, in accordance with the
rules set out in Annex VIII to said regulation.
6. MORETTI SpA maintains and provides to the competent authorities, for at least ten years
from the date of manufacture of the last production lot, the technical documentation
proving conformity with Regulation (EU) 2017/745.
Class I medical device
of 5 April 2017 on medical devices
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